Aquestive Therapeutics, Inc. - AQST STOCK NEWS

Aquestive Therapeutics (NASDAQ: AQST) announced on September 25, 2020, that the FDA issued a Complete Response Letter (CRL) concerning its New Drug Application (NDA) for Libervant™, a buccal film for treating seizure clusters. The CRL noted lower-than-desired drug exposure levels in specific weight groups. No additional clinical studies are expected, and no safety or manufacturing issues were identified. The company plans to resubmit the NDA to the FDA by year-end 2020, aiming for approval in the first half of 2021.

Aquestive Therapeutics (NASDAQ: AQST) has commenced a Phase 1 study for AQST-108, an oral sublingual film for treating allergic reactions, including anaphylaxis. The trial will dose 28 healthy volunteers and compare AQST-108's pharmacokinetics against subcutaneous and intramuscular epinephrine. Data is anticipated in Q4 2020. This formulation addresses unmet needs in managing anaphylaxis, where hospital admissions have surged by 500-700% over the last decade. The FDA granted AQST-108 Fast Track designation, endorsing its potential in this vital health area.

Aquestive Therapeutics (AQST) announced receipt of FDA Fast Track designation for AQST-108, an oral sublingual film for treating allergic reactions, including anaphylaxis. The first pharmacokinetic (PK) clinical trial is set to begin by Q3 2020, following FDA approval of the investigational new drug (IND). AQST-108 aims to address the unmet need for an alternative to traditional epinephrine injections, benefiting a substantial patient population hesitant to use standard treatments. This designation facilitates communication with the FDA and may lead to expedited review processes.

Aquestive Therapeutics (AQST) reported a strong 59% year-over-year revenue growth, totaling $21.7 million for Q2 2020.

The growth stems from increased sales of Sympazan® and revenue from KYNMOBI™ licensing.

The FDA has approved the IND for AQST-108, allowing the start of PK trials, and the company is advancing Libervant™ through the FDA review process.

Despite a net loss of $2.3 million, the adjusted EBITDA improved to $2.9 million. The company reaffirms its 2020 guidance, expecting total revenues of $35 million to $45 million.

Aquestive Therapeutics (NASDAQ: AQST) will report its second quarter results on August 4, 2020, followed by a conference call on August 5 at 8:00 a.m. ET. The company is focused on developing innovative pharmaceutical products, using advanced technologies to address unmet medical needs, particularly in CNS conditions. Their ongoing product candidates include AQST-108 and Libervant. The release also emphasizes potential risks related to FDA approvals and the impacts of COVID-19 on clinical trials and operations.

Aquestive Therapeutics (NASDAQ: AQST) announced the submission of an IND application to the FDA for AQST-108, an innovative oral sublingual film delivering systemic epinephrine, aimed at treating anaphylaxis. The company plans to initiate pharmacokinetic clinical trials by year-end 2020, utilizing the 505(b)(2) regulatory approval pathway. The trials will compare the pharmacokinetics of AQST-108 against conventional injection methods. A Phase 1 study indicated promising results, showing AQST-108's potential to meet an unmet medical need in patients who resist injection options.

Aquestive Therapeutics (NASDAQ:AQST) announced its participation in the BMO Capital Markets 2020 Prescriptions for Success Healthcare Conference, scheduled for June 23, 2020, at 8:30 AM EDT. The company will deliver a presentation and is available for one-on-one meetings during the event. A webcast of the presentation will be accessible on the company's website, with a replay available for 30 days post-event. Aquestive Therapeutics focuses on developing innovative treatments for CNS conditions and collaborates with other pharmaceutical firms to bring new therapies to market.

Aquestive Therapeutics (NASDAQ: AQST) has transitioned its Annual Meeting of Stockholders to a virtual-only format due to COVID-19 health concerns. The meeting is scheduled for June 16, 2020, at 9:30 a.m. ET. Stockholders can participate online starting at 9:15 a.m. ET, with rights to vote and ask questions remotely. Access requires a 15-digit control number and the password AQST2020. The company is considering future meeting formats based on ongoing health assessments.

Aquestive Therapeutics (NASDAQ:AQST) has announced plans to monetize anticipated royalties from Sunovion Pharmaceuticals’ FDA-approved apomorphine sublingual film, APL-130277. This product addresses motor fluctuations in Parkinson's disease patients. CEO Keith J. Kendall expressed optimism about generating $50 to $100 million in non-dilutive capital through royalty monetization, which could extend the company's capital runway into 2021. The company had previously granted Sunovion a license for the film, which is a part of its strategy to provide innovative treatment solutions.